The crucial decision on banning a number of controversial drugs, which have been either restricted or withdrawn in many countries, continues to be delayed inordinately with the Drug Technical Advisory Board (DTAB) still sitting on the matter and the health ministry ruling out any action without a recommendation from the DTAB.
The Health Ministry sources told that the matter was still with the DTAB and a final decision on these controversial drugs would be taken depending on the recommendation of the DTAB and the report was still awaited. The ministry also said it had received many representations especially from some public interest groups over the matter in the past, but would not take any action based on these complaints.
On the other hand, it is learnt from the DCGI office that the DTAB was yet to make a final call on these matters as many sub-committees have been made to look into the matters relating to different drugs under question. The sources refused to give a deadline on when the matter would be finally decided.
The issues related to the safety aspects of drugs such as nimesulide, gatifloxacin, tegaserod, rosiglitazone etc, have been referred to the DTAB and some of them were pending for long period now, even as a number of public interest groups have been raising concern over the matter and an early decision by the health ministry.
The list of controversial drugs is led by nimesulide, a non-steroidal anti-inflammatory drug, which has been banned in many countries but is being marketed in India aggressively by prominent drug companies. Nimesulide is marketed by Dr Reddys Labs, Piramal Lifesciences, Alembic etc., gatifloxacin by Aristo Pharma, Torrent Pharm, Piramal, Cipla Ltd etc., tegaserod by Emcure, Torrent, Intas etc., rosiglitazone by Dr Reddys, Torrent, Emcure, Cipla etc. Though it had been placed under the National Pharmacovigilance Programme, no adverse drug reaction report had been received about its use.
In case of anti-diabetic drug, rosiglitazone also, the ministry sources ruled out any immediate action before the examination and recommendation of the DTAB, though it was under scanner in many countries. Rosiglitazone is sold by GlaxoSmithKline Pharmaceuticals Ltd and generic versions are made by Sun Pharmaceuticals Ltd, Dr Reddy’s Laboratories Ltd and Torrent Pharmaceuticals Ltd, among 30 other firms. GlaxoSmithKline sells the drug as Avandia overseas and Windia in India.